Progressive muscle relaxation technique in the care of anxiety and pain in the cancer patient

• Register: ISRCTN
• Last refreshed on: 5 June 2018
• Main ID: ISRCTN81335752
• Date of registration: 22/11/2016
• Prospective Registration: No
• Primary sponsor: Universidad de Cantabria
• Public title: Progressive muscle relaxation technique in the care of anxiety and pain in the cancer patient
• Scientific title: Is the muscle relaxation technique capable of improving the quality of life of cancer patients with anxiety and pain?
• Date of first enrolment: 01/11/2014
• Target sample size: 272
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN81335752
• Study type: Interventional
• Study design: Non-randomised study (Quality of life)

Countries of recruitment

Spain

Contacts

• Name: Paula Parás-Bravo

Key inclusion & exclusion criteria

Inclusion criteria: 1. Age 18 years and over
2. Cancer patients
3. Experiencing anxiety, muscle tension, sleeping difficulties, sadness, or anxiety attacks
4. Provision of consent to participate
Exclusion criteria: Patients suffering from hallucinations, delirium or other psychotic symptoms.

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Anxiety, pain and nausea in cancer patients
Signs and Symptoms
Anxiety, pain and nausea in cancer patients

Intervention(s)

All participants receive a guided session in order to learn abbreviated progressive muscle relaxation training by following Bernstein and Borkovec. These sessions are conducted individually or in groups, according to the patients’ condition. All researchers who perform the intervention are fully trained regarding the selection criteria, information provided to participants, data collection procedures and application of the technique in order to unify criteria and reduce possible inter-examiner bias. All researchers receive a written guidance document for the relaxation session. The patients perform the technique in a sitting position in rooms furnished with armchairs, cushions, pleasant lighting and an overall quiet environment. Each session last approximately 60 minutes and is divided into the following 4 parts:
1. An explanation regarding the characteristics of the abbreviated progressive muscle relaxation training by Bernstein and Borkovec
2. Application of a relaxation session
3. Answering possible questions
4. Data collection using the self-administered FACT-G questionnaire and the data collection notebook.

At the end of the session, patients are provided with information regarding the intervention consisting of a brief description of the session, based on text and images, in order to support the performance of this technique at their respective homes. Participants are advised to perform the technique at home at least once a day for the duration of the study.

Participants are followed up weekly for one month.

Primary Outcome(s)

1. Quality of life is measured using the FACT-G (Functional Assessment of Cancer Therapy - General) questionnaire at baseline and weekly for four weeks (1 month)
2. Anxiety is measured using a visual analogue scale (VAS) at baseline and weekly for four weeks (1 month)
3. Pain is measured using a visual analogue scale (VAS) at baseline and weekly for four weeks (1 month)
4. Nausea is measured by asking participants a yes/no question about their nausea levels at baseline and weekly for four weeks (1 month)

Secondary Outcome(s)

1. Analgesic use is measured through patient interviews at baseline and weekly for four weeks (1 month)
2. Anxiolytic use is measured through patient interviews at baseline and weekly for four weeks (1 month)
3. Hypnotics use is measured through patient interviews at baseline and weekly for four weeks (1 month)
4. Antidepressant use is measured through patient interviews at baseline and weekly for four weeks (1 month)

Secondary ID(s)

Proyecto tesis

Source(s) of Monetary Support

Investigator initiated and funded

Ethics review

Status:
Approval date:
Contact:

1. Ethical Committee of Cantabria, 29/05/2014, ref: 2014.097 2. Alcorcon Hospital Ethics Committee, 03/11/2014 3. Ethical Committee Fuenlabrada Hospital, 03/12/2014 4. Ethical Committee Getafe Hospital, 26/06/2014, ref: A13-14 5. Ethical Committee Puerta Del Hierro Hospital, 27/07/2014, ref: Huph Pi92/14 6. Ethical Committee Instituto Catalan Oncologia Badalona,14/11/2014, ref: Jacobson 01/2014 7. Ethical Committee Instituto Catalan Oncologia Hospitalet, 10/09/2014, ref: Acta 15-14 8. Ethics Com

Results

• Results available: Yes
• Date Completed: 01/05/2016